Migalastat
Generic name: migalastat [ mi-GAL-a-stat ]
Brand name: Galafold
Dosage form: oral capsule (123 mg)
Drug class:Miscellaneous metabolic agents
What is migalastat?
Migalastat works by binding to and stabilizing a certain enzyme in the body called alpha-galactosidase A. A deficiency of this enzyme is called Fabry disease.
Migalastat is used to treat Fabry disease in adults.
Migalastat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to migalastat, but further studies are needed.
Migalastat may also be used for purposes not listed in this medication guide.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
Tell your doctor if you have ever had kidney problems.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, your name may be listed on a registry to track the effects of migalastat on the baby.
Migalastat is not approved for use by anyone younger than 18 years old.
How should I take migalastat?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take migalastat on an empty stomach, at least 2 hours before or 2 hours after a meal.
Migalastat is usually taken every other day, at the same time of day.
Swallow the capsule whole and do not crush, chew, break, or open it.
Do not take migalastat 2 days in a row.
Store at room temperature away from moisture and heat. Keep unused capsules in the blister pack.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking migalastat?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Migalastat side effects
Get emergency medical help if you have signs of an allergic reaction:hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor if you have:
pain or burning when you urinate.
Common side effects of migalastat may include:
